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eCTD: Easing the Transition

Presenters: Rohit Malhotra, Director, European Regulatory Operations and Affairs, Octagon Research Solutions Limited

Gareth Williams, PhD, Principal Consultant, Octagon Research Solutions, Inc.

The 5 Biggest Challenges of eCTD

Presenters: Patrick Thomas, Associate Director, Regulatory Affairs, Octagon Research Solutions, Inc.

Janel Demeter, Sr. Specialist, Regulatory Operations, Octagon Research Solutions, Inc.

Regulatory Submissions and Advisory Committee Meetings Series: Preparing Your Organization for Success

Part 1: Preparing Content:

Presenters Nancy Smerkanich, Vice President Regulatory Affairs, Octagon Research Solutions, Inc.

Bob Befus, President, Presentation Strategies

>> Click here to download a pdf

Regulatory Submissions and Advisory Committee Meetings Series: Preparing Your Organization for Success

Part 2: Preparing the Team

Presenters:Nancy Smerkanich, Vice President Regulatory Affairs, Octagon Research Solutions, Inc,

Bob Befus, President, Presentation Strategies

>> Click here to download a pdf

Regulatory Submissions and Advisory Committee Meetings Series: Preparing Your Organization for Success

Part 3: Pulling it all Together

Presenters: Nancy Smerkanich, Vice President Regulatory Affairs, Octagon Research Solutions, Inc.

Bob Befus, President, Presentation Strategies

>> Click here to download a pdf

Part2: Implementation Approaches to Structred Product Labeling (SPL)

Presenters: Michelle McGuinness, Director, Product Strategy, Octagon Research Solutions, Inc.

Ron Celeste, President, ThinSpring

>> Click here to download a pdf

Part 1: Introduction to Structured Product Labeling (SPL)

Presenters: Nancy Smerkanich, Vice President, Regulatory Affairs, Octagon Research Solutions, Inc.

Ron Celeste, President, ThinSpring

>> Click here to download a pdf